Amsterdam 510k Workshop on October 8-11, 2018

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October 8-11, 2018 there is a four-day, Amsterdam 510k workshop for medical devices at the Doubletree by Hilton Amsterdam Centraal Station.


The Amsterdam 510k Workshop is expanding this year to include more speakers, we will also be including discussions about the new Regulation (EU) 2017/745 (EU MDR). Each day of the workshop has a theme, and you can register for one or more days @ $499/day.

  • October 8, 2018 – Biocompatibility, Sterilization & ISO 10993 Updates
  • October 9, 2018 – 510k Process, ISO 13485:2016, MDSAP & FDA Inspections
  • October 10, 2018 – Mobile Devices, Cybersecurity, IEC 60601 updates & IEC 60601-1-2 4th edition 
  • October 11, 2018 –  CERs, PMS, PMCF & Preparing for the EU MDR

A networking lunch is included registration fee for each day, and all attendees will receive electronic copies of the presentations, a hardcopy of the book “How to Prepare Your 510k in 100 Days,” and a flash drive with a complete set of 510k document templates. More important than what you receive, is what you will learn.

Register for Amsterdam 510k workshop on October 8-11, 2018

Home Page Image 150x150 Amsterdam 510k Workshop on October 8 11, 2018
Amsterdam 510k Workshop 2018 – Day 1

Amsterdam 510k Workshop 2018 – Day 1 – Monday, October 8.

Price: $499.00

Home Page Image 150x150 Amsterdam 510k Workshop on October 8 11, 2018
Amsterdam 510k Workshop 2018 – Day 2

Amsterdam 510k Workshop 2018 – Day 2 – Tuesday, October 9.

Price: $499.00

Home Page Image 150x150 Amsterdam 510k Workshop on October 8 11, 2018
Amsterdam 510k Workshop 2018 – Day 3

Amsterdam 510k Workshop 2018 – Day 3 – Wednesday, October 10.

Price: $499.00

Home Page Image 150x150 Amsterdam 510k Workshop on October 8 11, 2018
Amsterdam 510k Workshop 2018 – Day 4

Amsterdam 510k Workshop 2018 – Day 4 – Thursday, October 11.

Price: $499.00

We can also invoice you if you for the Amsterdam 510k workshop prefer or provide a receipt invoice for tax purposes. Just send an email to: rob@13485cert.com. We also accept payments via PayPal, Squareup and Zelle the same email address.

You can ONLY get the 510k book by attending Medical Device Academy’s Amsterdam 510k workshop or by purchasing the on-line 510k course.

Where is the Amsterdam 510k workshop located?Exterior 300x200 Amsterdam 510k Workshop on October 8 11, 2018

DoubleTree by Hilton Amsterdam Centraal Station

Oosterdoksstraat 4, Amsterdam, 1011 DKNetherlands

Call for Directions & Reservations: +31-20-5300800

Click on the picture to the right in order to get reduced hotel rates when you register.

Speaker biographies for the Amsterdam 510k workshop

Pix Rob Packard zoom 150x150 Amsterdam 510k Workshop on October 8 11, 2018

Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.

Cropped Pix of Niels van Tienen 150x150 Amsterdam 510k Workshop on October 8 11, 2018

Niels is Director of Education and Training for Factory-CRO in the Netherlands. Factory-CRO’s clinical team organizes and supervises clinical investigations in Europe and the US, including a variety of medical writing activities for medical devices companies. Factory-CRO provides regulatory, clinical trial and clinical evaluation services. Niels is responsible for managing clinical study projects for medical device and IVD clients, and he has a Health Science Masters Degree from Maastricht University. He will be a guest speaker at the Amsterdam workshop sharing his Clinical Study Testing (Section 20) expertise. Niels also presented a free webinar on Medical Device Clinical Study Requirements on August 9, 2017.

Niels Van Tienen MSc – Director, Education and Training

Phone: +31 30 229 2727 (x171) | Cell: +31 6 52357492| Email: n.vantienen@factory-cro.com

Prof. Bronkhorstlaan 10 Bld. 54 | 3723 MB Bilthoven | The Netherlands

35ebc9d Amsterdam 510k Workshop on October 8 11, 2018Leo is the Principal Consultant of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, an expert in product safety for medical electrical devices (IEC 60601 series of standards), has been heavily involved in standards development focused on the IEC 60601 series of standards including working on IEC 60601-1, 3rd ed. + Amendment 2 (due out late 2019), has worked for several Notified Bodies as an auditor & technical reviewer, and is an expert in CE marking for the medical device directive.  He has over 30 years experience in product safety, and he routinely speaks all over the world as an international expert on the topic of electrical safety and IEC 60601-1. During the Workshop Leo will be discussing Electrical Safety & EMC Testing (Section 17).

Leonard (Leo) Eisner – Principal Consultant of Eisner Safety Consultants

Phone: +1 503 244 6151 Cell: +1 503 709 8328 Email: leo@eisnersafety.com

3331 SW Seymour Street Portland OR, 97239

Mary Vater Amsterdam 510k Workshop on October 8 11, 2018Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.  As a guest speaker, Mary is going to explain how design controls and risk management should be integrated with the process of your 510k preparation.

Mary Vater – Consultant for Medical Device Academy

Email: mary@fdaecopy.com

adam headshot 240x300 150x150 Amsterdam 510k Workshop on October 8 11, 2018Adam is a human factors expert. He has an M.B.A. in International Business from the Fox School of Business and Management at Temple University and a B.S. in Human Factors Engineering and Psychology (double major). From Tufts University. He has over a decade of extensive research experience, and has conducted hundreds of usability studies with thousands of participants around the world. He has also been the principal investigator on numerous successful IRB reviewed studies. As a guest speaker, Adam will be explaining how to design and conduct human factors studies for your 510k submission.

Adam Shames – Founder & CEO of Core human Factors, Inc.

France Office: 10 rue du Colisée 75008 PARIS

Phone: +33 (0)1 56 88 49 17

Email: shames@corehf.com

Head Shot from LinkedIn for Wolfgang Huber 150x150 Amsterdam 510k Workshop on October 8 11, 2018Wolfgang Huber is Co-Founder of Matrix Requirement Medical. He is a software engineer that will be speaking on IEC 62304 and the requirements for software documentation in a 510k submission. His company developed a web-based application to help medical devices organize documentation (requirements, specifications, use cases, tests, risk analysis) for their Design History File (DHF). The software eliminates the need to exchange word documents, maintains version control and automatically creates a traceability matrix. The company website includes testimonials for customers that use the software for creating their 510k submission documents.

Wolfgang Huber – Co-Founder of Matrix Requirement Medical

Email: wolfgang@matrixreq.com

Thor Rollins Cropped Amsterdam 510k Workshop on October 8 11, 2018Thor Rollins is Director of Toxicology and Extractables and Leachables (E&L) Consulting at Nelson Laboratories, LLC in Salt Lake City, Utah. He is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the Northern Cali Biomed ASQ group meeting in 2010 and 2012 as well as published articles on biocompatibility topics.

He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.

Thor Rollins – Director, of Toxicology and Extractables and Leachables (E&L) Consulting Nelson Labs

Phone: +1.801.290.7832

Email: trollins@nelsonlabs.com

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